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NCT01419197 · ADVERSE EVENTS

Adverse events

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy · Source last updated 2016-10-12

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
Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).
Other-event reporting threshold
5%

Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trastuzumab Emtansine

Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

102 / 403371 / 403Not reported / Not reported
Treatment of Physician's Choice (TPC)

Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.

41 / 184148 / 184Not reported / Not reported
Trastuzumab Emtansine - Post TPC Treatment Switch

Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

19 / 9474 / 94Not reported / Not reported

Group identifiers: EG000: Trastuzumab Emtansine · EG001: Treatment of Physician's Choice (TPC) · EG002: Trastuzumab Emtansine - Post TPC Treatment Switch

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Granulocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Hypercalcaemia of malignancy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Abdominal pain upper

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 (16.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      94
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      94
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      94
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      94
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      94
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      94
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Gingival bleeding
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      144
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      94
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Stomatitis
Complete source fields
description
Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).
event Groups
  1. description
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    id
    EG000
    other Num Affected
    371
    other Num At Risk
    403
    serious Num Affected
    102
    serious Num At Risk
    403
    title
    Trastuzumab Emtansine
  2. description
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    id
    EG001
    other Num Affected
    148
    other Num At Risk
    184
    serious Num Affected
    41
    serious Num At Risk
    184
    title
    Treatment of Physician's Choice (TPC)
  3. description
    Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    id
    EG002
    other Num Affected
    74
    other Num At Risk
    94
    serious Num Affected
    19
    serious Num At Risk
    94
    title
    Trastuzumab Emtansine - Post TPC Treatment Switch
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      94
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      94
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      94
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      94
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      94
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      94
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Gingival bleeding
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      144
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      94
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Granulocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Hypercalcaemia of malignancy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      403
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      184
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    term
    Abdominal pain upper
time Frame
Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice