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NCT01013649 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery · Source last updated 2026-02-23

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
Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years.
Other-event reporting threshold
5%

Note that adverse events from Arm I and II participants who continued to step 2 randomization will also appear in the adverse events for Arms III and IV.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)

Participants receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

38 / 160158 / 160103 / 160
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)

\[Closed to accrual 2-28-2014.\] Participants receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

45 / 158157 / 158100 / 158
Arm III (Chemotherapy)

Participants receive the same treatment as in arm I or arm II for one month. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

33 / 174173 / 174136 / 174
Arm IV (Chemotherapy, Chemoradiotherapy)

Participants receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, Participants undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, Participants receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

31 / 180179 / 180134 / 180

Group identifiers: EG000: Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) · EG001: Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) · EG002: Arm III (Chemotherapy) · EG003: Arm IV (Chemotherapy, Chemoradiotherapy)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      180
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      180
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      180
    term
    Chest pain - cardiac
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      180
    term
    Heart failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Restrictive cardiomyopathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      180
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      180
    term
    Ascites

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      142
      num At Risk
      180
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      180
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      180
    term
    Blurred vision
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      180
    term
    Abdominal distension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      85
      num At Risk
      180
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      180
    term
    Ascites
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      180
    term
    Bloating
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      180
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      87
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      112
      num At Risk
      180
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      180
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      180
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      180
    term
    Flatulence
Complete source fields
description
Note that adverse events from Arm I and II participants who continued to step 2 randomization will also appear in the adverse events for Arms III and IV.
event Groups
  1. deaths Num Affected
    103
    deaths Num At Risk
    160
    description
    Participants receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    EG000
    other Num Affected
    158
    other Num At Risk
    160
    serious Num Affected
    38
    serious Num At Risk
    160
    title
    Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
  2. deaths Num Affected
    100
    deaths Num At Risk
    158
    description
    \[Closed to accrual 2-28-2014.\] Participants receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    EG001
    other Num Affected
    157
    other Num At Risk
    158
    serious Num Affected
    45
    serious Num At Risk
    158
    title
    Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
  3. deaths Num Affected
    136
    deaths Num At Risk
    174
    description
    Participants receive the same treatment as in arm I or arm II for one month. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    EG002
    other Num Affected
    173
    other Num At Risk
    174
    serious Num Affected
    33
    serious Num At Risk
    174
    title
    Arm III (Chemotherapy)
  4. deaths Num Affected
    134
    deaths Num At Risk
    180
    description
    Participants receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, Participants undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, Participants receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Participants undergo CT, MRI, and/or x-ray imaging throughout the trial. Participants also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    EG003
    other Num Affected
    179
    other Num At Risk
    180
    serious Num Affected
    31
    serious Num At Risk
    180
    title
    Arm IV (Chemotherapy, Chemoradiotherapy)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      139
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      142
      num At Risk
      180
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      180
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      180
    term
    Blurred vision
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      180
    term
    Abdominal distension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      85
      num At Risk
      180
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      180
    term
    Ascites
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      180
    term
    Bloating
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      180
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      87
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      112
      num At Risk
      180
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      180
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      180
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      180
    term
    Flatulence
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      180
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      180
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      180
    term
    Chest pain - cardiac
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      180
    term
    Heart failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Restrictive cardiomyopathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      180
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      180
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      174
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      180
    term
    Ascites
time Frame
Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years.

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Preserved source evidence · Not medical advice