| A | B | C | D | E | F | G | H | I | J | |
|---|---|---|---|---|---|---|---|---|---|---|
1 | subjectId | deviationId | visitDesignator | dvCat | epoch | dvSeq | source | actSite | cape | dvTerm |
2 | 10011001 | 1-1JI8LRA | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
3 | 10011001 | 1-1LGBQFB | SCR | Non-Important | SCREENING | 2 | ANPD | 1001 | NO | Procedure/Test not performed per protocol |
4 | 10011002 | 1-1JI8LRE | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
5 | 10011003 | 1-1JI8M0O | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
6 | 10011004 | 1-1JI8M0S | SCR | Non-Important | SCREENING | 2 | ANPD | 1001 | NO | Procedure/Test not done |
7 | 10011004 | 1-1K3AOWB | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Procedure/Test not done |
8 | 10011004 | 1-1KM4RCB | V6_WEEK2_POSTVAX2_S | Non-Important | FOLLOW-UP | 4 | ANPD | 1001 | NO | Procedure/Test performed out of window |
9 | 10011005 | 1-1JI8M0W | SCR | Non-Important | SCREENING | 4 | ANPD | 1001 | NO | Procedure/Test not done |
10 | 10011005 | 1-1K3AOWF | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 5 | ANPD | 1001 | NO | Procedure/Test not done |
11 | 10011005 | 1-1KM4RCE | V6_WEEK2_POSTVAX2_S | Non-Important | FOLLOW-UP | 6 | ANPD | 1001 | NO | Procedure/Test performed out of window |
12 | 10011005 | 1-1OAJFUR | COVID_A | Non-Important | FOLLOW-UP | 3 | ANPD | 1001 | NO | Lab performed out of window |
13 | 10011005 | 1-1RRSIMX | V4_WEEK3_VAX2_S | Important | REPEAT SCREENING 1 | 2 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
14 | 10011005 | 1-1RRSIN1 | V4_WEEK3_VAX2_S | Important | REPEAT SCREENING 1 | 1 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
15 | 10011006 | 1-1JI8M10 | SCR | Non-Important | SCREENING | 2 | ANPD | 1001 | NO | Procedure/Test not done |
16 | 10011006 | 1-1K3AOWI | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Procedure/Test not done |
17 | 10011006 | 1-1KM4RCR | V6_WEEK2_POSTVAX2_S | Non-Important | FOLLOW-UP | 4 | ANPD | 1001 | NO | Procedure/Test performed out of window |
18 | 10011006 | 1-1KXT62P | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure not performed as part of vital signs. |
19 | 10011007 | 1-1JI8M14 | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
20 | 10011007 | 1-1KL8O1L | Unschedule Teleheath Visit | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Visit not done |
21 | 10011007 | 1-1KM4RCU | V6_WEEK2_POSTVAX2_S | Non-Important | FOLLOW-UP | 2 | ANPD | 1001 | NO | Procedure/Test performed out of window |
22 | 10011008 | 1-1JI8M1I | SCR | Non-Important | SCREENING | 2 | ANPD | 1001 | NO | Procedure/Test not done |
23 | 10011008 | 1-1K3BWG3 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Procedure/Test not done |
24 | 10011008 | 1-1KM4RCX | V6_WEEK2_POSTVAX2_S | Non-Important | FOLLOW-UP | 4 | ANPD | 1001 | NO | Procedure/Test performed out of window |
25 | 10011008 | 1-1KQTA2E | Consent | Non-Important | FOLLOW-UP | 1 | ANPD | 1001 | NO | Other Informed Consent |
26 | 10011009 | 1-1JFBTJH | Consent | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Other Informed Consent |
27 | 10011009 | 1-1JI8M1M | SCR | Non-Important | SCREENING | 4 | ANPD | 1001 | NO | Procedure/Test not done |
28 | 10011009 | 1-1K3BWG6 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 5 | ANPD | 1001 | NO | Procedure/Test not done |
29 | 10011009 | 1-1KXT62T | SCR | Non-Important | SCREENING | 3 | ANPD | 1001 | NO | Procedure not performed as part of vital signs. |
30 | 10011009 | 1-1L9JOW0 | V1_DAY1_VAX1_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Subject was vaccinated despite meeting temporary delay criterion #1 (current febrile illness or other acute illness within 48 hrs before study intervention administration. Includes current symptoms that could represent a potential COVID-19 illness. |
31 | 10011010 | 1-1JP0N6S | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
32 | 10011011 | 1-1JP0N6V | SCR | Non-Important | SCREENING | 3 | ANPD | 1001 | NO | Procedure/Test not done |
33 | 10011011 | 1-1K8KYZD | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Procedure not performed as part of vital signs. |
34 | 10011011 | 1-1R0YDKL | COVID_A | Non-Important | FOLLOW-UP | 1 | ANPD | 1001 | NO | Nasal swab not collected for the visit where it is required |
35 | 10011012 | 1-1JP0N6Y | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
36 | 10011013 | 1-1JP0N7B | SCR | Non-Important | SCREENING | 5 | ANPD | 1001 | NO | Procedure/Test not done |
37 | 10011013 | 1-1KFHO1S | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 4 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
38 | 10011013 | 1-1KFHO1V | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
39 | 10011013 | 1-1LKF7CP | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Other IP deviation |
40 | 10011013 | 127173801 | Vax 3 | Non-Important | REPEAT SCREENING 1 | 1 | ICON | 1001 | NO | IP Documentation Error - Confirmation of Treatment - Received Form errors |
41 | 10011014 | 1-1JP0N7E | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
42 | 10011015 | 1-1JP0N7H | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
43 | 10011016 | 1-1JP0N7K | SCR | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Procedure/Test not done |
44 | 10011021 | 1-1JVJ258 | SCR | Non-Important | SCREENING | 5 | ANPD | 1001 | NO | Procedure/Test not done |
45 | 10011021 | 1-1KM11HV | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 4 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
46 | 10011021 | 1-1KM11HY | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
47 | 10011021 | 1-1LKF7CT | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Other IP deviation |
48 | 10011021 | 126632101 | Vax 3 | Non-Important | OPEN LABEL TREATMENT | 1 | ICON | 1001 | NO | IP Documentation Error - Confirmation of Treatment - Received Form errors |
49 | 10011026 | 1-1JVJ25M | SCR | Non-Important | SCREENING | 3 | ANPD | 1001 | NO | Procedure/Test not done |
50 | 10011026 | 1-1KFHOBF | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
51 | 10011026 | 1-1LKF7CY | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 1 | ANPD | 1001 | NO | Other IP deviation |
52 | 10011028 | 1-1JVJ25S | SCR | Non-Important | SCREENING | 3 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
53 | 10011028 | 1-1JY98JV | V1_DAY1_VAX1_S | Non-Important | VACCINATION | 4 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
54 | 10011028 | 1-1JY98K0 | V2_DAY2_POSTVAX1_S | Non-Important | VACCINATION | 5 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
55 | 10011028 | 1-1KM11I1 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 6 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
56 | 10011028 | 1-1KM4RBW | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
57 | 10011028 | 1-1LKF7EF | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 1 | ANPD | 1001 | NO | Other IP deviation |
58 | 10011030 | 1-1KM4RBZ | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
59 | 10011030 | 1-1KM4RC2 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
60 | 10011030 | 1-1LKF7EJ | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 1 | ANPD | 1001 | NO | Other IP deviation |
61 | 10011032 | 1-1LKF7F9 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 1 | ANPD | 1001 | NO | Other IP deviation |
62 | 10011032 | 1-1LKF7FD | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
63 | 10011034 | 1-1JVJ25P | SCR | Non-Important | SCREENING | 4 | ANPD | 1001 | NO | Procedure/Test not done |
64 | 10011034 | 1-1KM4RC5 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 3 | ANPD | 1001 | NO | Urine pregnancy test not performed. |
65 | 10011034 | 1-1KM4RC8 | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 2 | ANPD | 1001 | NO | Nasal swab not collected by site staff prior to vaccination. |
66 | 10011034 | 1-1LKF7EM | V4_WEEK3_VAX2_S | Non-Important | VACCINATION | 1 | ANPD | 1001 | NO | Other IP deviation |
67 | 10011040 | 1-1NRYTMX | POT_COVID_CONVA | Non-Important | FOLLOW-UP | 2 | ANPD | 1001 | NO | Visit performed outside of protocol specified window. |
68 | 10011041 | 1-1NZLLYL | POT_COVID_ILL | Non-Important | FOLLOW-UP | 2 | ANPD | 1001 | NO | Potential COVID-19 illness visit not done when required per protocol. |
69 | 10011041 | 1-1QYBYBE | Potential ReVax Initial Contact | Important | REPEAT SCREENING 1 | 1 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
70 | 10011042 | 1-1R6ZGTR | V4_WEEK3_VAX2_S | Important | REPEAT SCREENING 1 | 1 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
71 | 10011042 | 1-1SSS15S | POT_COVID_ILL | Non-Important | REPEAT SCREENING 1 | 2 | ANPD | 1001 | NO | Potential COVID-19 illness visit not done when required per protocol. |
72 | 10011043 | 126637401 | Vax 2 | Non-Important | VACCINATION | 2 | ICON | 1001 | NO | IP verification incomplete |
73 | 10011043 | 128799601 | Vax 3 | Non-Important | REPEAT SCREENING 1 | 1 | ICON | 1001 | NO | IP Documentation Error - Confirmation of Treatment - Received Form errors |
74 | 10011044 | 1-1SK6OGJ | Potential ReVax Initial Contact | Important | REPEAT SCREENING 1 | 1 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
75 | 10011046 | 1-1L3POMG | V4_WEEK3_VAX2_S | Non-Important | FOLLOW-UP | 1 | ANPD | 1001 | NO | Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. |
76 | 10011047 | 1-1L24D3D | Consent | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Other Informed Consent |
77 | 10011048 | 1-1LNZ1PP | SCR | Non-Important | SCREENING | 2 | ANPD | 1001 | NO | Procedure/Test not performed per protocol |
78 | 10011048 | 1-1LNZ1PV | SCR | Non-Important | SCREENING | 3 | ANPD | 1001 | NO | Procedure/Test not performed per protocol |
79 | 10011048 | 126637701 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
80 | 10011049 | 126637901 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
81 | 10011052 | 126638201 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
82 | 10011053 | 1-1SKKCBA | Potential ReVax Initial Contact | Important | REPEAT SCREENING 1 | 1 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
83 | 10011053 | 1-1SKKCBD | Potential ReVax Initial Contact | Important | REPEAT SCREENING 1 | 2 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
84 | 10011053 | 126638401 | Vax 2 | Non-Important | VACCINATION | 3 | ICON | 1001 | NO | IP verification incomplete |
85 | 10011055 | 126638801 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
86 | 10011057 | 126638901 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
87 | 10011058 | 1-1KP8XJS | Consent | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Subject/LAR signed and dated ICD after screen/enroll date |
88 | 10011058 | 126639001 | Vax 2 | Non-Important | VACCINATION | 2 | ICON | 1001 | NO | IP verification incomplete |
89 | 10011059 | 126639101 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
90 | 10011061 | 1-1QSQ8I0 | COVID_A1 | Non-Important | REPEAT SCREENING 1 | 2 | ANPD | 1001 | NO | Visit performed outside of protocol specified window. |
91 | 10011061 | 126639201 | Vax 2 | Non-Important | VACCINATION | 1 | ICON | 1001 | NO | IP verification incomplete |
92 | 10011064 | 126639401 | Vax 2 | Non-Important | VACCINATION | 2 | ICON | 1001 | NO | IP verification incomplete |
93 | 10011064 | 127436401 | Vax 3 | Non-Important | OPEN LABEL TREATMENT | 1 | ICON | 1001 | NO | IP Documentation Error - Confirmation of Treatment - Received Form errors |
94 | 10011069 | 126632201 | Vax 3 | Non-Important | OPEN LABEL TREATMENT | 1 | ICON | 1001 | NO | IP Documentation Error - Confirmation of Treatment - Received Form errors |
95 | 10011070 | 1-1KXT62X | V1_DAY1_VAX1_S | Non-Important | VACCINATION | 1 | ANPD | 1001 | NO | Procedure not performed as part of vital signs. |
96 | 10011071 | 1-1L86RWN | Consent | Non-Important | FOLLOW-UP | 1 | ANPD | 1001 | NO | Other Informed Consent |
97 | 10011074 | 1-1KU8SIE | Consent | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Other Informed Consent |
98 | 10011077 | 1-1KVEIHY | Consent | Non-Important | SCREENING | 1 | ANPD | 1001 | NO | Other Informed Consent |
99 | 10011081 | 1-1R6ZGTV | V2_VAX2_L | Important | REPEAT SCREENING 1 | 1 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |
100 | 10011081 | 1-1R6ZGTY | V2_VAX2_L | Important | REPEAT SCREENING 1 | 2 | ANPD | 1001 | YES-POP2,YES-POP3 | Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. |