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NCT02718417 · FLOW

Participant flow

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) · Source last updated 2020-07-14

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

groups
  1. description
    In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    FG000
    title
    Chemotherapy Followed by Avelumab
  2. description
    In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    FG001
    title
    Chemotherapy + Avelumab Followed by Avelumab
  3. description
    In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
    id
    FG002
    title
    Chemotherapy Followed by Observation
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        13
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Death leading to discontinuation
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Global deterioration of health status
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      No longer met eligibility criteria
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Physician's decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        10
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        15
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        332
      2. group Id
        FG001
        num Subjects
        331
      3. group Id
        FG002
        num Subjects
        335
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        328
      2. group Id
        FG001
        num Subjects
        329
      3. group Id
        FG002
        num Subjects
        334
      comment
      Participants who had received at least one dose of study drug
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        280
      2. group Id
        FG001
        num Subjects
        294
      3. group Id
        FG002
        num Subjects
        289
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        46
      type
      NOT COMPLETED
    title
    Chemotherapy Phase (CP)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Death leading to discontinuation
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Global deterioration of health status
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      No longer met eligibility criteria
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician's decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    9. reasons
      1. group Id
        FG000
        num Subjects
        114
      2. group Id
        FG001
        num Subjects
        140
      3. group Id
        FG002
        num Subjects
        0
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. comment
        Included participants without evidence of disease progression at the end of Chemotherapy phase.
        group Id
        FG000
        num Subjects
        267
      2. comment
        Included participants without evidence of disease progression at the end of Chemotherapy phase.
        group Id
        FG001
        num Subjects
        288
      3. comment
        After completing CP, participants moved to observation phase. MP was not applicable for this arm.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        266
      2. group Id
        FG001
        num Subjects
        287
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance Phase (MP)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Death leading to discontinuation
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        92
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        135
      type
      Study terminated by sponsor
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        34
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Global deterioration of health status
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Other
    milestones
    1. achievements
      1. comment
        After completing MP, participants moved to follow-up phase. OP was not applicable.
        group Id
        FG000
        num Subjects
        0
      2. comment
        After completing MP, participants moved to follow-up phase. OP was not applicable.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Included participants without evidence of disease progression at the end of Chemotherapy phase.
        group Id
        FG002
        num Subjects
        284
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        282
      type
      NOT COMPLETED
    title
    Observation Phase (OP)
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        138
      3. group Id
        FG002
        num Subjects
        6
      type
      Study terminated by sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      type
      Death leading to discontinuation
    milestones
    1. achievements
      1. comment
        Participants not completing MP could also start this phase.
        group Id
        FG000
        num Subjects
        238
      2. comment
        Participants not completing MP could also start this phase.
        group Id
        FG001
        num Subjects
        263
      3. comment
        Participants not completing OP could also start this phase.
        group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        172
      3. group Id
        FG002
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Follow-up Phase
  5. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        11
      type
      Death leading to discontinuation
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        80
      3. group Id
        FG002
        num Subjects
        112
      type
      Study terminated by sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. comment
        Participants not completing follow-up phase could also start this phase.
        group Id
        FG000
        num Subjects
        139
      2. comment
        Participants not completing follow-up phase could also start this phase.
        group Id
        FG001
        num Subjects
        112
      3. comment
        Participants not completing follow-up could also start this phase.
        group Id
        FG002
        num Subjects
        135
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        139
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        135
      type
      NOT COMPLETED
    title
    Long-term Follow-up Phase
Complete source fields
groups
  1. description
    In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    FG000
    title
    Chemotherapy Followed by Avelumab
  2. description
    In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    FG001
    title
    Chemotherapy + Avelumab Followed by Avelumab
  3. description
    In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
    id
    FG002
    title
    Chemotherapy Followed by Observation
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        13
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Death leading to discontinuation
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Global deterioration of health status
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      No longer met eligibility criteria
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Physician's decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        10
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        15
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        332
      2. group Id
        FG001
        num Subjects
        331
      3. group Id
        FG002
        num Subjects
        335
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        328
      2. group Id
        FG001
        num Subjects
        329
      3. group Id
        FG002
        num Subjects
        334
      comment
      Participants who had received at least one dose of study drug
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        280
      2. group Id
        FG001
        num Subjects
        294
      3. group Id
        FG002
        num Subjects
        289
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        46
      type
      NOT COMPLETED
    title
    Chemotherapy Phase (CP)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Death leading to discontinuation
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Global deterioration of health status
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      No longer met eligibility criteria
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician's decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    9. reasons
      1. group Id
        FG000
        num Subjects
        114
      2. group Id
        FG001
        num Subjects
        140
      3. group Id
        FG002
        num Subjects
        0
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. comment
        Included participants without evidence of disease progression at the end of Chemotherapy phase.
        group Id
        FG000
        num Subjects
        267
      2. comment
        Included participants without evidence of disease progression at the end of Chemotherapy phase.
        group Id
        FG001
        num Subjects
        288
      3. comment
        After completing CP, participants moved to observation phase. MP was not applicable for this arm.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        266
      2. group Id
        FG001
        num Subjects
        287
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance Phase (MP)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Death leading to discontinuation
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        92
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        135
      type
      Study terminated by sponsor
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        34
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Global deterioration of health status
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Other
    milestones
    1. achievements
      1. comment
        After completing MP, participants moved to follow-up phase. OP was not applicable.
        group Id
        FG000
        num Subjects
        0
      2. comment
        After completing MP, participants moved to follow-up phase. OP was not applicable.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Included participants without evidence of disease progression at the end of Chemotherapy phase.
        group Id
        FG002
        num Subjects
        284
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        282
      type
      NOT COMPLETED
    title
    Observation Phase (OP)
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        138
      3. group Id
        FG002
        num Subjects
        6
      type
      Study terminated by sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      type
      Death leading to discontinuation
    milestones
    1. achievements
      1. comment
        Participants not completing MP could also start this phase.
        group Id
        FG000
        num Subjects
        238
      2. comment
        Participants not completing MP could also start this phase.
        group Id
        FG001
        num Subjects
        263
      3. comment
        Participants not completing OP could also start this phase.
        group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        172
      3. group Id
        FG002
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Follow-up Phase
  5. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        11
      type
      Death leading to discontinuation
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        80
      3. group Id
        FG002
        num Subjects
        112
      type
      Study terminated by sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. comment
        Participants not completing follow-up phase could also start this phase.
        group Id
        FG000
        num Subjects
        139
      2. comment
        Participants not completing follow-up phase could also start this phase.
        group Id
        FG001
        num Subjects
        112
      3. comment
        Participants not completing follow-up could also start this phase.
        group Id
        FG002
        num Subjects
        135
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        139
      2. group Id
        FG001
        num Subjects
        112
      3. group Id
        FG002
        num Subjects
        135
      type
      NOT COMPLETED
    title
    Long-term Follow-up Phase

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Preserved source evidence · Not medical advice