Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00753415 · ADVERSE EVENTS

Adverse events

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002) · Source last updated 2015-03-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Other-event reporting threshold
5%

Participants who completed Part A had the option to enter Part B.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: V935 LD

Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.

1 / 33 / 3Not reported / Not reported
Part A: V934 LD(3)+V935 LD

Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.

0 / 33 / 3Not reported / Not reported
Part A: V935 HD

Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.

2 / 108 / 10Not reported / Not reported
Part A: V934 HD(3)+V935 HD

Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

2 / 1111 / 11Not reported / Not reported
Part A: V934 HD(5)+V935 HD

Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

1 / 1010 / 10Not reported / Not reported
Part B: V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

0 / 11 / 1Not reported / Not reported
Part B: V934 LD(3)+V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

0 / 21 / 2Not reported / Not reported
Part B: V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

0 / 73 / 7Not reported / Not reported
Part B: V934 HD(3)+V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

0 / 98 / 9Not reported / Not reported
Part B: V934 HD(5)+V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

0 / 97 / 9Not reported / Not reported

Group identifiers: EG000: Part A: V935 LD · EG001: Part A: V934 LD(3)+V935 LD · EG002: Part A: V935 HD · EG003: Part A: V934 HD(3)+V935 HD · EG004: Part A: V934 HD(5)+V935 HD · EG005: Part B: V935 LD/V934 Booster · EG006: Part B: V934 LD(3)+V935 LD/V934 Booster · EG007: Part B: V935 HD/V934 Booster · EG008: Part B: V934 HD(3)+V935 HD/V934 Booster · EG009: Part B: V934 HD(5)+V935 HD/V934 Booster

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pericardial effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Upper gastrointestinal haemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Lobar pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Coronary artery stenosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Haematocrit decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Bladder cancer
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Depressed mood

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      9
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Conjunctival haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Food poisoning
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Gastritis
Complete source fields
description
Participants who completed Part A had the option to enter Part B.
event Groups
  1. description
    Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part A: V935 LD
  2. description
    Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Part A: V934 LD(3)+V935 LD
  3. description
    Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Part A: V935 HD
  4. description
    Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    EG003
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    2
    serious Num At Risk
    11
    title
    Part A: V934 HD(3)+V935 HD
  5. description
    Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    EG004
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    1
    serious Num At Risk
    10
    title
    Part A: V934 HD(5)+V935 HD
  6. description
    Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    EG005
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part B: V935 LD/V934 Booster
  7. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part B: V934 LD(3)+V935 LD/V934 Booster
  8. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    7
    serious Num Affected
    0
    serious Num At Risk
    7
    title
    Part B: V935 HD/V934 Booster
  9. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    EG008
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    0
    serious Num At Risk
    9
    title
    Part B: V934 HD(3)+V935 HD/V934 Booster
  10. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    EG009
    other Num Affected
    7
    other Num At Risk
    9
    serious Num Affected
    0
    serious Num At Risk
    9
    title
    Part B: V934 HD(5)+V935 HD/V934 Booster
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      9
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Conjunctival haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Food poisoning
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Gastritis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pericardial effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Upper gastrointestinal haemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Lobar pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Coronary artery stenosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Haematocrit decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Bladder cancer
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      9
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Depressed mood
time Frame
SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice