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NCT02923349 · ADVERSE EVENTS

Adverse events

A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors · Source last updated 2025-08-24

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
From screening through 60 days after end of treatment, up to 11 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PART 1 Dose 1 (7 mg)

INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

1 / 44 / 41 / 4
PART 1 Dose 2 (20 mg)

INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

1 / 44 / 40 / 4
PART 1 Dose 3 (70 mg)

INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

8 / 2221 / 222 / 22
PART 1 Dose 4 (200 mg)

INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

9 / 1817 / 184 / 18
PART 1 Dose 5 (350 mg)

INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

9 / 2322 / 232 / 23
PART 1 Dose 6 (700 mg)

INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

5 / 1210 / 123 / 12
PART 1 Dose 7 (1400 mg)

INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

1 / 44 / 40 / 4

Group identifiers: EG000: PART 1 Dose 1 (7 mg) · EG001: PART 1 Dose 2 (20 mg) · EG002: PART 1 Dose 3 (70 mg) · EG003: PART 1 Dose 4 (200 mg) · EG004: PART 1 Dose 5 (350 mg) · EG005: PART 1 Dose 6 (700 mg) · EG006: PART 1 Dose 7 (1400 mg)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ataxia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Blood bilirubin increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Cancer pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Cauda equina syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Colitis

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Amylase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Arthralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ataxia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Blood alkaline phosphatase increased
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    PART 1 Dose 1 (7 mg)
  2. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    PART 1 Dose 2 (20 mg)
  3. deaths Num Affected
    2
    deaths Num At Risk
    22
    description
    INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG002
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    8
    serious Num At Risk
    22
    title
    PART 1 Dose 3 (70 mg)
  4. deaths Num Affected
    4
    deaths Num At Risk
    18
    description
    INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG003
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    9
    serious Num At Risk
    18
    title
    PART 1 Dose 4 (200 mg)
  5. deaths Num Affected
    2
    deaths Num At Risk
    23
    description
    INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG004
    other Num Affected
    22
    other Num At Risk
    23
    serious Num Affected
    9
    serious Num At Risk
    23
    title
    PART 1 Dose 5 (350 mg)
  6. deaths Num Affected
    3
    deaths Num At Risk
    12
    description
    INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG005
    other Num Affected
    10
    other Num At Risk
    12
    serious Num Affected
    5
    serious Num At Risk
    12
    title
    PART 1 Dose 6 (700 mg)
  7. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    PART 1 Dose 7 (1400 mg)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Amylase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Arthralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ataxia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Blood alkaline phosphatase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Ataxia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Blood bilirubin increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Cancer pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Cauda equina syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Colitis
time Frame
From screening through 60 days after end of treatment, up to 11 months

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Preserved source evidence · Not medical advice