Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer · Source last updated 2016-06-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percent of patients in category
Interval / dispersion
Not reported
Time frame
Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
What was measured
This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.
Analysis population: ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.
Groups in this outcome
MM-398 Arm A (Mono Therapy Comparison)
• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
* 5-FU 2400 mg/m2 IV over 46-hours, and
* Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
5-FU + Leucovorin (Combo Therapy Comparison)
* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
MM-398 Arm A (Mono Therapy Comparison)
105
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
83
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
71
5-FU + Leucovorin (Combo Therapy Comparison)
57
Reported measurements
Global Health Status: Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
10
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
17
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
12
Not reported
Not reported
Not reported
Not reported
Global Health Status: Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
31
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
41
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
38
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
44
Not reported
Not reported
Not reported
Not reported
Global Health Status: Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
57
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
48
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
45
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
44
Not reported
Not reported
Not reported
Not reported
Physical Functioning: Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
10
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
10
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
Physical Functioning: Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
29
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
37
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
41
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
40
Not reported
Not reported
Not reported
Not reported
Physical Functioning: Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
61
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
52
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
49
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
49
Not reported
Not reported
Not reported
Not reported
Role Functioning: Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
6
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
10
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
15
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
Role Functioning: Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
29
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
39
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
32
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
37
Not reported
Not reported
Not reported
Not reported
Role Functioning: Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
66
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
52
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
52
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
53
Not reported
Not reported
Not reported
Not reported
Emotional Functioning:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
10
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
8
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
20
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
9
Not reported
Not reported
Not reported
Not reported
Emotional Functioning:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
32
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
59
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
46
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
58
Not reported
Not reported
Not reported
Not reported
Emotional Functioning:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
56
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
33
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
34
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
33
Not reported
Not reported
Not reported
Not reported
Cognitive Functioning:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
12
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
6
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
11
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
7
Not reported
Not reported
Not reported
Not reported
Cognitive Functioning:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
32
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
42
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
48
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
44
Not reported
Not reported
Not reported
Not reported
Cognitive Functioning:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
54
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
52
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
41
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
49
Not reported
Not reported
Not reported
Not reported
Social Functioning:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
13
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
Social Functioning:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
26
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
43
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
34
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
47
Not reported
Not reported
Not reported
Not reported
Social Functioning:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
62
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
46
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
54
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
42
Not reported
Not reported
Not reported
Not reported
Fatigue:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
13
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
14
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
12
Not reported
Not reported
Not reported
Not reported
Fatigue:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
18
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
30
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
20
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
33
Not reported
Not reported
Not reported
Not reported
Fatigue:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
69
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
59
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
66
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
54
Not reported
Not reported
Not reported
Not reported
Nausea and Vomiting:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
5
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
6
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
13
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
Nausea and Vomiting:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
37
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
42
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
32
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
46
Not reported
Not reported
Not reported
Not reported
Nausea and Vomiting:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
58
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
52
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
55
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
51
Not reported
Not reported
Not reported
Not reported
Pain:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
20
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
10
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
27
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
11
Not reported
Not reported
Not reported
Not reported
Pain:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
30
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
37
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
34
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
40
Not reported
Not reported
Not reported
Not reported
Pain:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
50
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
53
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
39
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
49
Not reported
Not reported
Not reported
Not reported
Dyspnoea:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
10
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
6
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
7
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
5
Not reported
Not reported
Not reported
Not reported
Dyspnoea:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
47
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
69
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
51
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
68
Not reported
Not reported
Not reported
Not reported
Dyspnoea:Worsoned
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
44
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
24
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
42
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
25
Not reported
Not reported
Not reported
Not reported
Insomnia:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
9
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
18
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
5
Not reported
Not reported
Not reported
Not reported
Insomnia:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
43
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
49
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
34
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
49
Not reported
Not reported
Not reported
Not reported
Insomnia:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
48
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
47
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
48
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
46
Not reported
Not reported
Not reported
Not reported
Appetite Loss:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
9
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
6
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
11
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
5
Not reported
Not reported
Not reported
Not reported
Appetite Loss:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
38
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
42
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
45
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
46
Not reported
Not reported
Not reported
Not reported
Appetite Loss:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
53
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
52
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
44
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
49
Not reported
Not reported
Not reported
Not reported
Constipation:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
13
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
13
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
Constipation:Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
47
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
63
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
56
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
67
Not reported
Not reported
Not reported
Not reported
Constipation:Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
39
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
34
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
31
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
30
Not reported
Not reported
Not reported
Not reported
Diarrhoea:Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
6
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
4
Not reported
Not reported
Not reported
Not reported
Diarrhoea: Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
35
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
58
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
39
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
58
Not reported
Not reported
Not reported
Not reported
Diarrhoea: Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
59
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
39
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
55
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
39
Not reported
Not reported
Not reported
Not reported
Financial Difficulties: Improved
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
6
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
1
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
8
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
0
Not reported
Not reported
Not reported
Not reported
Financial Difficulties: Stable
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
51
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
67
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
51
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
74
Not reported
Not reported
Not reported
Not reported
Financial Difficulties: Worsened
Values in percent of patients in category · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
MM-398 Arm A (Mono Therapy Comparison)
42
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
31
Not reported
Not reported
Not reported
Not reported
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
41
Not reported
Not reported
Not reported
Not reported
5-FU + Leucovorin (Combo Therapy Comparison)
26
Not reported
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
group Description
Comparison of Global Health Status
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6388
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Global Health Status
group Ids
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.8445
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Physical Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6388
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Physical Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.9435
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Role functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2654
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Role functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7674
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Emotional Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1628
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Emotional Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6712
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Cognitive Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7738
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Cognitive Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6712
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Social Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3408
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Social Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6712
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
Complete source fields
analyses
group Description
Comparison of Global Health Status
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6388
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Global Health Status
group Ids
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.8445
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Physical Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6388
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Physical Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.9435
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Role functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2654
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Role functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7674
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Emotional Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1628
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Emotional Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6712
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Cognitive Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7738
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Cognitive Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6712
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Social Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3408
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
group Description
Comparison of Social Functioning
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6712
p Value Comment
For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false
classes
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
11
group Id
OG002
value
17
group Id
OG003
value
12
title
Global Health Status: Improved
categories
measurements
group Id
OG000
value
31
group Id
OG001
value
41
group Id
OG002
value
38
group Id
OG003
value
44
title
Global Health Status: Stable
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
48
group Id
OG002
value
45
group Id
OG003
value
44
title
Global Health Status: Worsened
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
11
group Id
OG002
value
10
group Id
OG003
value
11
title
Physical Functioning: Improved
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
37
group Id
OG002
value
41
group Id
OG003
value
40
title
Physical Functioning: Stable
categories
measurements
group Id
OG000
value
61
group Id
OG001
value
52
group Id
OG002
value
49
group Id
OG003
value
49
title
Physical Functioning: Worsened
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
10
group Id
OG002
value
15
group Id
OG003
value
11
title
Role Functioning: Improved
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
39
group Id
OG002
value
32
group Id
OG003
value
37
title
Role Functioning: Stable
categories
measurements
group Id
OG000
value
66
group Id
OG001
value
52
group Id
OG002
value
52
group Id
OG003
value
53
title
Role Functioning: Worsened
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
8
group Id
OG002
value
20
group Id
OG003
value
9
title
Emotional Functioning:Improved
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
59
group Id
OG002
value
46
group Id
OG003
value
58
title
Emotional Functioning:Stable
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
33
group Id
OG002
value
34
group Id
OG003
value
33
title
Emotional Functioning:Worsened
denoms
counts
group Id
OG000
value
105
group Id
OG001
value
83
group Id
OG002
value
71
group Id
OG003
value
57
units
Participants
description
This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.
groups
description
• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
id
OG000
title
MM-398 Arm A (Mono Therapy Comparison)
description
* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
id
OG001
title
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
description
* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.
* 5-FU 2400 mg/m2 IV over 46-hours, and
* Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
id
OG002
title
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
description
* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle
* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
id
OG003
title
5-FU + Leucovorin (Combo Therapy Comparison)
param Type
NUMBER
population Description
ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.
reporting Status
POSTED
time Frame
Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
Triangle